NCT02851459

Brief Summary

This study is the first phase of a trial examining decision making about vaccines. This phase tests the impact of targeted vaccine-focused health messages on vaccine beliefs held by parents of young children and pre-adolescents. The participant's vaccine beliefs will be assessed at baseline. Two weeks later, the participant's moral matrix will be assessed. A vaccine-related message that appeals to the individual's three most or least emphasized moral foundations will then be presented. Immediately afterwards, vaccine beliefs will be assessed to determine the impact of the message.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
850

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

March 10, 2017

Status Verified

March 1, 2017

Enrollment Period

2 months

First QC Date

July 28, 2016

Last Update Submit

March 9, 2017

Conditions

Keywords

Vaccines

Outcome Measures

Primary Outcomes (2)

  • Overall change in attitude towards vaccines

    Number of caregivers experiencing a change in attitude towards vaccines.

    Week 2

  • Intent to have their children vaccinated

    Number of caregivers opting to have their children vaccinated.

    Week 2

Study Arms (3)

Morally Congruent Message

EXPERIMENTAL

Participants randomized to this arm will receive a vaccine-related message developed to appeal to their three most-emphasized moral foundations.

Behavioral: Baseline SurveyBehavioral: Pre-intervention SurveyBehavioral: Morally Congruent MessageBehavioral: Post-Intervention Survey

Morally Non-Congruent Message

EXPERIMENTAL

Participants randomized to this arm will receive a vaccine-related message developed to appeal to their three least-emphasized moral foundations.

Behavioral: Baseline SurveyBehavioral: Pre-intervention SurveyBehavioral: Morally Non-Congruent MessageBehavioral: Post-Intervention Survey

Control Message

SHAM COMPARATOR

Participants randomized to the control arm will be provided with a short passage about the costs and benefits of bird feeding.

Behavioral: Baseline SurveyBehavioral: Pre-intervention SurveyBehavioral: Control MessageBehavioral: Post-Intervention Survey

Interventions

Baseline SurveyBEHAVIORAL

The baseline survey contains questions regarding level of existing vaccine hesitancy (Parent Attitudes about Childhood Vaccines (PACV) short scale and HealthStyles questions), demographic information, and intent to vaccinate their children. All study surveys will be completed on an electronic device.

Control MessageMorally Congruent MessageMorally Non-Congruent Message

Participants will be contacted two weeks after completing the baseline survey to answer questions about their moral beliefs. The survey will include questions form the Moral Foundations Questionnaire as well as additional questions. An algorithm will calculate the participant's moral matrix based on answers to these questions.

Control MessageMorally Congruent MessageMorally Non-Congruent Message

Intervention messages consist of four short paragraphs. The first three focus on how getting vaccinated helps uphold specific moral foundations. The fourth summarizes the contents of the prior paragraphs. Participants randomized to the morally congruent arm will receive a vaccine-related message developed to appeal to their three most-emphasized moral foundations. The first paragraph focuses on the most emphasized foundation, the second on the third-most emphasized, and the third on the second-most emphasized.

Also known as: Morally Congruent Vaccine Focused Message
Morally Congruent Message

Intervention messages consist of four short paragraphs. The first three focus on how getting vaccinated helps uphold specific moral foundations. Participants randomized to the morally non-congruent arm will receive a vaccine-related message developed to appeal to their three least-emphasized moral foundations. The first paragraph focuses on the least emphasized foundation, the second on the third-least emphasized, and the third on the second-least emphasized.

Also known as: Morally Non-Congruent Vaccine Focused Message
Morally Non-Congruent Message
Control MessageBEHAVIORAL

Participants randomized to the control arm will be provided with a short passage about the costs and benefits of bird feeding.

Control Message

Immediately after reading the randomly assigned message participants will complete a follow-up survey assessing level of existing vaccine hesitancy (PACV short scale and HealthStyles questions) and intent to vaccinate their children.

Control MessageMorally Congruent MessageMorally Non-Congruent Message

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Have at least one child ≤ 12 years of age
  • Reside in the United States

You may not qualify if:

  • Have previously participated in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University School Of Public Health - Only Online Recruitment

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Saad B Omer, BBS, MPH, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 28, 2016

First Posted

August 1, 2016

Study Start

August 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

March 10, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations